SIST EN ISO 5366-1:2009

SLOVENSKI STANDARD
SIST EN ISO 5366-1:2009
01-julij-2009
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SIST EN ISO 5366-1:2005
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Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and
connectors for use in adults (ISO 5366-1:2000)
Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und
Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie - Partie 1:
Tubes et raccords pour adultes (ISO 5366-1:2000)
Ta slovenski standard je istoveten z: EN ISO 5366-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5366-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5366-1:2009

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SIST EN ISO 5366-1:2009
EUROPEAN STANDARD
EN ISO 5366-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 5366-1:2004
English Version
Anaesthetic and respiratory equipment - Tracheostomy tubes -
Part 1: Tubes and connectors for use in adults (ISO 5366-
1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes Anästhesie- und Beatmungsgeräte - Tracheotomietuben -
de trachéostomie - Partie 1: Tubes et raccords pour adultes Teil 1: Tuben und Verbindungsstücke zur Anwendung bei
(ISO 5366-1:2000) Erwachsenen (ISO 5366-1:2000)
This European Standard was approved by CEN on 21 March 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5366-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (E)
Foreword
The text of ISO 5366-1:2000 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 5366-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5366-1:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 5366-1:2000 has been approved by CEN as a EN ISO 5366-1:2009 without any modification.
3

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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (E)
Annex ZA
(Informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 – Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
1 N/A
2 N/A
3 N/A
4 1, 2 a), 3
5 1, 2 a), 3, 7.1 a), 7.1 b), 7.2
6 1, 2, 3, 9.2 a)
6.1 4, 9.1, 9.3
6.1.1 7.5
6.1.4 7.5
6.2 4
6.3 9.1, 9.3
6.4.1 4
6.4.2 4
6.5.2.1 2 b)
6.5.3 9.1
6.7 4
7.1 8.1, 8.3, 8.4
7.2.2 5, 8.1, 8.3
8.1 13.2, 13.3 g) – m), 13.4
8.2 13.1
8.2.1 a) 13.3 b)
8.2.1 b) 13.3 b), 2 c)
8.2.1 c) 13.3 a)
8.3 13.1, 13.3 e)
8.3.1 13.2
8.3.2 a) 13.3 b), 13.4
8.3.2 b) 13.3 b)
8.3.2 d) 13.3 b)
8.3.2 e) 13.3 b)
8.3.2 f) 13.3 b)
4

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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (E)

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
8.3.2 g) 13.3 a)
8.3.2 h) 13.3 d), 13.5
8.3.2 i) 8.6, 13.6 h)
8.3.2 j) 8.1, 8.3, 8.7, 13.2, 13.3 b), c)
8.3.2 k) 13.3 b)
8.3.2 l) 2 c), 13.3 b)
8.3.3 13.3 e)
8.3.3 a) 13.3 b), 13.4
8.3.3 b) 13.3 b)
8.3.3 c) 13.3 b)
8.3.3 d) 13.3 a)
8.3.3 e) 13.3 d), 13.5
8.3.3 f) 8.6, 13.6 h)
8.3.3 g) 8.1, 8.3, 8.7, 13.2, 13.3 b), c)
8.3.3 h) 13.3 b), d) – f), 13.5
Annex C 4, 7.1 b), 7.3, 9.2 a)
C.1.2 13.6 h)
C.1.3 9.3
- 1 These parts of this
(2nd paragraph, 1st dash) Essential Requirement
 are not addressed in this
(2nd paragraph, 2nd dash) Standard
- 6a) This part of this
Essential Requirement is
not addressed in this
Standard
- 7.1 (3rd dash) This part of this
Essential Requirement is
not addressed in this
Standard
- 7.5 (1st paragraph) This part of this
Essential Requirement is
not fully addressed in
this European Standard
- 7.5 (2nd paragraph) This part of this
Essential Requirement is
not fully addressed in
this European Standard
- 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this
European Standard
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SIST EN ISO 5366-1:2009
EN ISO 5366-1:2009 (E)

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.6 (h)(3rd paragraph) This relevant Essential
Requirement is not
addressed in this
European Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this
European Standard
N/A = not applicable

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.

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SIST EN ISO 5366-1:2009
INTERNATIONAL ISO
STANDARD 5366-1
Fourth edition
2000-12-15
Corrected and reprinted
2001-09-01
Anaesthetic and respiratory equipment —
Tracheostomy tubes —
Part 1:
Tubes and connectors for use in adults
Matériel d'anesthésie et de réanimation respiratoire — Tubes de
trachéostomie —
Partie 1: Tubes et raccords pour adultes
Reference number
ISO 5366-1:2000(E)
© ISO 2000

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SIST EN ISO 5366-1:2009
ISO 5366-1:2000(E)
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©
ii ISO 2000 – All rights reserved

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SIST EN ISO 5366-1:2009
ISO 5366-1:2000(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Size designation and dimensions . 4
5 Materials . 6
6 Design and finish . 6
7 Requirements for tracheostomy tubes supplied sterile . 7
8 Marking and labelling . 8
Annexes
A Test method for the security of attachment of connector and neck-plate to tracheostomy tube. 10
A.1 Principle . 10
A.2 Apparatus . 10
A.3 Procedure . 10
A.4 Expression of results . 10
B Test method for determining the resting diameter of the cuff. 11
B.1 Principle . 11
B.2 Apparatus . 11
B.3 Procedure . 11
B.4 Expression of results . 11
C Guidance on materials and design . 12
C.1 Materials . 12
C.2 Design . 12
Bibliography. 13
©
ISO 2000 – All rights reserved iii

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SIST EN ISO 5366-1:2009
ISO 5366-1:2000(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical com-
mittees. Each member body interested in a subject for which a technical committee has been established has the
right to be represented on that committee. International organizations, governmental and non-governmental, in liai-
son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this part of ISO 5366 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 5366-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Tracheal tubes and other equipment.
This fourth edition cancels and replaces the third edition of ISO 5366-1 and the second edition of ISO 5366-2
(ISO 5366-1:1994 and ISO 5366-2:1993), which have been technically revised.
ISO 5366 consists of the following parts, under the general title Anaesthetic and respiratory equipment — Tracheos-
tomy tubes:
— Part 1: Tubes and connectors for use in adults
— Part 3: Paediatric tracheostomy tubes
Annexes A and B form a normative part of this part of ISO 5366. Annex C is for information only.
©
iv ISO 2000 – All rights reserved

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SIST EN ISO 5366-1:2009
ISO 5366-1:2000(E)
Introduction
ISO 5366-1 is one of a series of International Standards dealing with anaesthetic equipment, and is concerned with
the basic requirements and method of size designation of tracheostomy tubes made of plastics materials and/or rub-
ber. Specialized tubes, for example those without a connector at the machine end intended for spontaneously breath-
ing patients, and those with reinforced walls or tubes made of metal are excluded from the scope of this part of
ISO 5366.
This part of ISO 5366 specifies requirements for tracheostomy tubes with an inside diameter of 6,5 mm or greater.
ISO 5366-3 specifies requirements for tracheostomy tubes with an inside diameter from 2,0 to 6,0 mm for paediatric
use.
The method of describing tube dimensions and configuration has been devised in order to assist the clinician in the
selection of a suitable tube to conform as far as possible to a particular patient's anatomy. Size is designated by in-
side diameter, which is important because of its relation to resistance to gas flow. Because the stomal and tracheal
diameters are important when selecting tubes, it is considered essential that the outside diameter be stated for each
size of tube.
Cuffed tracheostomy tubes can be characterized by a combination of the tube inside and outside diameters and by
the cuff resting diameter.
The relationship of cuff and tracheal diameters dictates the intra-cuff pressures required to provide a seal. Excessive
pressure on the tracheal wall can obstruct capillary blood flow.
A range of cuff designs is available to meet the particular clinical requirements. This part of ISO 5366 requires that
the resting diameter of the cuff is marked on the unit package, as this information allows the clinician to match the
product to the application.
A 15 mm male conical connector in accordance with ISO 5356-1 should be used for tracheostomy tubes, as for tra-
cheal tubes, to ensure compatibility with the breathing system of an anaesthetic machine or ventilator.
The tracheostomy tube connector should be permanently attached to the tracheostomy tube to prevent inadvertent
disconnection of the connector from the tube.
Flammability of tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units, or lasers are used
1)
in oxidant-enriched atmospheres, is a well-recognized hazard that is addressed by appropriate clinical manage-
ment, and is outside the scope of this part of ISO 5366.
1) See ISO/TR 11991.
©
ISO 2000 – All rights reserved v

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SIST EN ISO 5366-1:2009

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SIST EN ISO 5366-1:2009
INTERNATIONAL STANDARD ISO 5366-1:2000(E)
Anaesthetic and respiratory equipment — Tracheostomy tubes —
Part 1:
Tubes and connectors for use in adults
1 Scope
This part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber having
inside diameters of 6,5 mm or greater. Such tubes are primarily designed for patients who require anaesthesia, arti-
ficial ventilation or other respiratory support, but need not be restricted to these uses.
This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomy
tubes.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 5366. For dated references, subsequent amendments to, or revisions of, any of these publications do
not apply. However, parties to agreements based on this part of ISO 5366 are encouraged to investigate the possi-
bility of applying the most recent editions of the normative documents indicated below. For undated references, the
latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently
valid International Standards.
ISO 594-1, Conical
...